title: Consent in critical care trials: a survey of Canadian research ethics boards and critical care researchers.
abstract: OBJECTIVE
  Reliance on third party consent for patients without decision-making capacity presents unique challenges for critical care research. We compared the attitudes and beliefs of Canadian research ethics boards (REBs) and intensive care unit researchers toward the use of various consent models for a low-risk randomized controlled trial.
  
  
  METHODS
  Self-administered, scenario-based survey.
  
  
  RESULTS
  Sixty-two percent of eligible REBs (n = 83) and 78% of eligible researchers (n = 124) completed the questionnaire. The REBs were less comfortable endorsing alternative consent models when a substitute decision maker was unavailable, including consent provided by (a) the intensivist involved with the trial (2.0% vs 15.3%; P = .014), (b) the intensivist not involved with the trial (10.0% vs 36.7%; P = .001), (c) 2 physicians (the intensivist and another consultant, neither of whom is involved with the trial) (18.0% vs 54.1%; P < .001), and (d) 2 physicians involved neither with the trial nor the patient's care (10.2% vs 52.0%; P < .001). In similar circumstances, REBs were less comfortable approving both deferred (8.0% vs 43.3%; P < .001) and waived (4.1% vs 22.4%; P = .005) consent.
  
  
  CONCLUSIONS
  In this survey of scenarios involving low-risk critical care research, REBs were significantly more conservative in approving alternative consent models compared with investigators.
authors.affiliation: McMaster Children's Hospital, Hamilton, Ontario, Canada. Electronic address: duffett@hhsc.ca.
authors.forename: Mark
authors.initials: M
authors.lastname: Duffett
authors.affiliation: St. Michael's Hospital, Toronto, Ontario, Canada.
authors.forename: Karen E
authors.initials: KE
authors.lastname: Burns
authors.affiliation: Johns Hopkins University, Baltimore, MD.
authors.forename: Michelle E
authors.initials: ME
authors.lastname: Kho
authors.affiliation: Université Laval, Québec City, Québec, Canada.
authors.forename: François
authors.initials: F
authors.lastname: Lauzier
authors.affiliation: McMaster Children's Hospital, Hamilton, Ontario, Canada.
authors.forename: Maureen O
authors.initials: MO
authors.lastname: Meade
authors.affiliation: McMaster Children's Hospital, Hamilton, Ontario, Canada.
authors.forename: Donald M
authors.initials: DM
authors.lastname: Arnold
authors.affiliation: Sunnybrook Health Sciences Centre and University of Toronto, Toronto, Ontario, Canada.
authors.forename: Neill K J
authors.initials: NKJ
authors.lastname: Adhikari
authors.affiliation: Université de Sherbrooke, Sherbrooke, Québec, Canada.
authors.forename: François
authors.initials: F
authors.lastname: Lamontagne
authors.affiliation: McMaster Children's Hospital, Hamilton, Ontario, Canada.
authors.forename: Deborah J
authors.initials: DJ
authors.lastname: Cook
mesh_terms: D001291:Attitude of Health Personnel; D002170:Canada; D003422:Critical Care / Q000941:ethics*; D003625:Data Collection; D028744:Ethics Committees, Research; D006801:Humans; D008962:Models, Theoretical; D016032:Randomized Controlled Trials as Topic / Q000941:ethics*; D012108:Research Personnel / Q000523:psychology*; D018570:Risk Assessment; D020458:Third-Party Consent / Q000941:ethics*